In 2007, for instance, a Dallas pharmaceutical compounding center was linked to deaths in Oregon and Washington.

In 2006, a Virginia compounder was sued for making a contaminated drug that doctors used in heart bypass surgery, according to a report from American Association for Justice. Four patients died.

And in 2001, three California patients died of meningitis traced to steroid injections from a compounding firm.

Through it all, compounders have fought off efforts to give the Food and Drug Administration more clearly defined regulatory authority over them. Among the most notable bills they have gunned down was the Safe Compounding and Drug Act of 2007, introduced by a bipartisan coalition of lawmakers headed by the late Sen. Edward M. Kennedy, D-Mass.

The International Academy of Compounding Pharmacists and other professional associations are “very vocal” and “able to exert a lot of influence,” said Michael Labson, a Washington attorney who specializes in food and drug issues. They defend the right of doctors to prescribe specialized medicines that can be mixed, or “compounded,” in the corner drug store.

The IACP alone has spent $1.1 million lobbying Congress over the past decade, according to the Center for Responsive Politics.

Its campaign contributions are small by the standard of most Washington special interests — $214,314 since 2006 — but are targeted at members of congressional committees who play key roles on health issues.

Rep. Marsha Blackburn, R-Brentwood, a member of the House Energy and Commerce Committee, has received $10,000 from the IACP political action committee since 2010.

Now, in the wake of 21 deaths and 271 illnesses across 16 states connected to contaminated steroids from the New England Compounding Center in Framingham, Mass., lawmakers are asking new questions about just what kind of regulatory matrix governs such enterprises.

FDA questions

Some contend the FDA, under its 1938 founding statute, already has all the legal authority it needed to shut down a facility like New England Compounding. Others say additional federal language is needed to separate mom-and-pop shops from mass-production enterprises like NECC.

The 1938 law gives the FDA regulatory authority over any “new drug,” and it should make no difference whether it is one produced by a major pharmaceutical company or a compounder, says Michael Carome, a doctor who monitors FDA issues for the watchdog group Public Citizen.

However, he said, the FDA has traditionally recognized that trying to police thousands of small-scale compounders in individual pharmacies nationwide is not feasible. The agency has also repeatedly recognized the medical value of such compounding and the role of state pharmacy boards in supervising it.

But in the 1990s, mass production of drugs by those claiming to be compounders became more widespread and the FDA grew more concerned.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which attempted to draw a bright line between traditional compounders and those that mass-produced. It also attempted to restrict large-scale compounders from advertising their drugs for interstate sales.

In reaction, compounders successfully challenged the 1997 law in the federal courts, arguing its advertising restrictions interfered with free speech. Some rulings struck down the whole the law. Others revoked just the advertising provisions, leaving what some interpret as a legal gray area concerning the FDA’s authority over large-scale compounders.

“It would be nice (for Congress) to clear up the legal confusion,” said Jeffrey Gibbs, another Washington attorney with experience in FDA litigation.

Kennedy’s 2007 bill was essentially an attempt to replace the 1997 bill, but without the advertising rules.

Inspections lacking

Carome, of Public Citizen, says the FDA might need additional money to better police mass-compounding but no new laws.

The FDA has several times shown its authority by issuing warning letters to compounders and did so to the New England Compounding Center in 2006. He said it should have followed up with further inspections and gone to court to get an injunction.

“They could have probably stopped (the current outbreak),” Carome said.

Since the start of the outbreak, lawmakers, including many from Tennessee, have besieged FDA Commissioner Margaret Hamburg with letters requesting clarification of the agency’s powers in regard to NECC-type operations.

A Republican co-sponsor of the 2007 Kennedy bill, Sen. Richard Burr of North Carolina, said Friday in a statement, “The current outbreak raises important questions regarding appropriate regulation of entities engaged in large-scale compounding that goes beyond meeting specific patient needs.”

Some, such as Rep. Edward Markey, D-Mass., are already calling for new laws on compounders.

The IACP, the main compounders lobbying group, has indicated a willingness to cooperate.

“If additional regulation or legislation could prevent another situation like the one we are dealing with now, then we stand ready to work with Congress and state legislators to make that happen,” spokesman David Ball said.

“NECC is alleged to have been operating outside of the law, and we are eager to learn from the investigation exactly what occurred there. Most important, whatever results from this must not disrupt legitimate patient care.”

TN lawmakers react

In the Tennessee delegation, Rep. Jim Cooper, D-Nashville, is among those saying any loophole allowing mass-production compounders to receive the same treatment as the corner drugstore needs to be closed immediately.

“This isn’t mixing up something special for Aunt Mary down the street,” Cooper said. “I’m increasingly doubtful the states can handle this.”

Republican Sens. Lamar Alexander and Bob Corker have asked the FDA to clarify what policy changes need to be made.

“Obviously, compounding pharmacies need clearer regulatory supervision,” Alexander said in a statement. “When the FDA finishes its investigation, we will do what needs to be done to try to make sure something like this never happens again.”